The regulation of animal biotechnology currently is performed under existing government agencies. To date, no new regulations or laws have been enacted to deal with animal biotechnology and related issues
The regulation of animal biotechnology currently is performed under existing government agencies. To date, no new regulations or laws have been enacted to deal with animal biotechnology and related issues. The main governing body for animal biotechnology and their products is the FDA. Specifically, these products fall under the new animal drug provisions of the Food, Drug, and Cosmetic Act (FDCA). In this use, the introduced genetic construct is considered the “drug.” This lack of concrete regulatory guidance has produced many questions, especially because the process for bringing genetically engineered animals to market remains unknown.
Currently, the only genetically engineered animal on the market is the GloFish, a transgenic aquarium fish engineered to glow in the dark. It has not been subject to regulation by the FDA, however, because it is not believed to be a threat to the environment.
Many people question the use of an agency that was designed specifically for drugs to regulate live animals. The agency’s strict confidentiality provisions and lack of an environmental mandate in the FDCA also are concerns. It still is unclear how the agency’s provisions will be interpreted for animals and how multiple agencies will work together in the regulatory system.
When animals are genetically engineered for biomedical research purposes (as pigs are, for example, in organ transplantation studies), their care and use is carefully regulated by the Department of Agriculture. In addition, if federal funds are used to support the research, the work further is regulated by the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
Labeling
Whether products generated from genetically engineered animals should be labeled is yet another controversy surrounding animal biotechnology. Those opposed to mandatory labeling say it violates the government’s traditional focus on regulating products, not processes. If a product of animal biotechnology has been proven scientifically by the FDA to be safe for human consumption and the environment and not materially different from similar products produced via conventional means, these individuals say it is unfair and without scientific rationale to single out that product for labeling solely because of the process by which it was made.
On the other hand, those in favor of mandatory labeling argue labeling is a consumer “right-to-know” issue. They say consumers need full information about products in the marketplace — including the processes used to make those products — not for food safety or scientific reasons, but so they can make choices in line with their personal ethics.
Intellectual Property
On average, it takes seven to nine years and an investment of about $55 million to develop, test and market a new genetically engineered product. Consequently, nearly all researchers involved in animal biotechnology are protecting their investments and intellectual property through the patent system. In 1988, the first patent was issued on a transgenic animal, a strain of laboratory mice whose cells were engineered to contain a cancer-predisposing gene. Some people, however, are opposed ethically to the patenting of life forms, because it makes organisms the property of companies. Other people are concerned about its impact on small farmers. Those opposed to using the patent system for animal biotechnology have suggested using breed registries to protect intellectual property.
According to aboutbioscience